This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Marketing Authorisation Holder:

AVENTIS PASTEUR MSD, SNC 8, rue Jonas Salk F-69007 Lyon France

Date of issue of Marketing Authorisation valid throughout the European Union:

23 October 2000

Orphan medicinal product designation date:

Not applicable

Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, polio virus and Haemophilus influenzae type b. It is developed for primary and booster vaccination of children against the viruses and bacteria mentioned above.

The approval was based on results from clinical trials, which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules. These studies showed the protective efficacy of Hexavac against the above diseases in infants.

The most common adverse events were transient local reactions (pain, redness, swelling at the injection site) and systemic reactions (loss of appetite, fever, drowsiness, irritability).

The CHMP, on the basis of quality, efficacy and safety data submitted, consideres that the overall benefit /risk ratio for Hexavac remains favourable in the approved indication.

For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules.

References:

European Medicines Agency

This document is a summary of the European public assessment report (EPAR) for Hexavac. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Hexavac.